Trials / Completed
CompletedNCT02660112
(+) Epicatechin to Treat Friedreich's Ataxia
A Phase II, Open Label Prospective Single Center Drug Study Evaluating the Safety and Efficacy of (+)-Epicatechin in Subjects With Friedreich's Ataxia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Ralitza Gavrilova · Academic / Other
- Sex
- All
- Age
- 10 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | (+)-Epicatechin | 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day) |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-12-30
- Completion
- 2018-12-30
- First posted
- 2016-01-21
- Last updated
- 2019-12-05
- Results posted
- 2019-12-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02660112. Inclusion in this directory is not an endorsement.